The present invention relates to a plug for sealing a percutaneous puncture in a vessel or artery, at the inner surface thereof.
During certain types of medical surgery or treatment an introducer is used to access the vascular system of a patient. The introducer is inserted through the wall of a blood vessel in order to obtain access to the vascular system and may thereafter be used for guiding medical instruments such as catheters, guide wires and the like. After the completion of the medical procedure there will be an incision or a wound in the wall of the blood vessel corresponding to the size of the introducer. The bleeding from the wound, which is the result of such a surgical operation, may be stopped by applying direct pressure on the wound. However, applying direct pressure on the wound will require assistance of medical personnel and may also restrict the blood flow through the vessel.
EP-766 947 A2 describes a hemostatic puncture device for sealing a percutaneous puncture. The main parts of this device are an anchoring means, a collagen foam acting as a sealing means, a filament means and carrier means. The device uses an introducer or the like in order to guide the different parts to the puncture. The anchoring means, which is a narrow, rigid beam member, is introduced through the puncture to be inserted into the vessel. During the introduction, the anchoring means is in a longitudinal position, in order to fit into the introducer. In order to function as an anchor the anchoring means is manipulated in such a way that its end portions grip the inner edges of the puncture. The anchoring means is connected to the sealing means by the filament means in a pulley-like configuration. Thus, after the anchoring means has been put in place and the introducer is withdrawn the pulley-like configuration will pull the sealing means towards the puncture and then eventually seal the puncture on the outside wall of the vessel. Thus, the collagen foam performs all the sealing, i.e. the puncture is only sealed on the outside wall of the vessel. The collagen foam is effective in stopping the flow of blood, but the closure device according to EP-766 947 has disadvantages. One such disadvantage is the risk that the local tension applied to the edges of the puncture by the anchoring means, which contacts the puncture edge at two sites only, will rupture the edges of the puncture. In addition, the use of a sealing that seals on the outside of the vessel requires higher sealing force than a corresponding inner sealing.
Based on U.S. Pat. No. 5,350,399, it is known to seal a puncture through a vessel with an intra-arterial occluder and an extra-arterial occluder, respectively. The occluders are made of resilient biocompatible and/or bioabsorbable material and are held together by a saw-toothed guide extending from the intra-arterial occluder. A similar sealing is also disclosed in U.S. Pat. No. 5,342,393 wherein inner and outer rivet members are joined by a stem extending from the inner rivet to seal a puncture.
In addition, another intra-arterial occluder is described in U.S. Pat. No. 4,852,568.
However, when using an intra-arterial occluder there is still a problem in that the edge of the puncture might rupture when a retracting force is applied to the stem of the intra-arterial occluder in order to urge it against the vessel wall. In addition, the occluder according to U.S. Pat. No. 5,342,393 includes small hook-like means to clamp the edge of the puncture in order to ensure the sealing function of the occluders. These hook-like means are also a possible source for damage to the edge of the puncture.
Thus, there is a need for an improved intra-arterial occluder that provides a safe sealing of a percutaneous puncture, and at the same time reduces the risk of a rupture in the vessel wall when applying a retracting force to the intra-arterial occluder in order to urge the occluder against the vessel wall.
According to one aspect of the present invention, an occluder for intra-arterial sealing a puncture in a vessel or artery is provided, comprising: a first portion having a length exceeding a first diameter of the puncture in a direction along the vessel or artery and a width less than a second diameter of the puncture in a direction transverse to the vessel or artery, said first portion having longitudinal edges; and a second portion positioned at least along said longitudinal edges of said first portion, wherein said first portion has a higher structural stiffness than the second portion.
According to another aspect of the present invention, an occluder positioned on an interior of a blood vessel or artery for sealing a puncture is provided, comprising: a central portion; and a rim portion operatively connected with said central portion, wherein said central portion has a relatively greater stiffness than said rim portion.
Further, according to yet another aspect of the present invention, a method of sealing a puncture in a blood vessel or artery, comprising the steps of: inserting an occluder into the puncture to the interior of the blood vessel or artery, said occluder comprising: a first portion having a length exceeding a first diameter of the puncture in a direction along the vessel or artery and a width less than a second diameter of the puncture in a direction transverse to the vessel or artery, said first portion having longitudinal edges, and a second portion positioned at least along said longitudinal edges of said first portion, wherein said first portion has a higher structural stiffness than the second portion; and moving said occluder relative to said blood vessel to engage said occluder with an interior wall of the blood vessel or artery.